Pediatric total facemask

ABSTRACT

A mask assembly ( 10 ) for use in a system delivering a flow of a treatment gas to the airway of a pediatric patient. The mask assembly includes a mask body ( 12 ) having an opening ( 13 ) adapted to receive a treatment gas supply and a flexible peripheral seal structure ( 20 ). The flexible seal structure includes a first side coupled to the mask body and an opposite second side having an opening adapted to receive the face of the pediatric patient such that the second side sealingly engages the perimeter of the pediatric patient&#39;s face. The opening is defined by a height (H l ) and a width (W l ). The ratio of the height to width of the opening is about 0.83.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the priority benefit under 35 U.S.C.§119(e) of U.S. Provisional Application No. 61/656,737 filed on Jun. 7,2012, the contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to therapeutic gas delivery systems and,more particularly, to a mask that forms a seal with a pediatricpatient's face during gas delivery.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in their esophagus. For example, it is known to ventilatea patient using a technique known as non-invasive ventilation (NIV). Itis also known to deliver continuous positive airway pressure (CPAP) orvariable airway pressure, which varies with the patient's respiratorycycle, to treat a medical disorder, such as sleep apnea syndrome, inparticular, obstructive sleep apnea (OSA), chronic obstructive pulmonarydisease (COPD), or congestive heart failure (CHF).

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device, which is typically a nasal ornasal/oral mask (i.e., a full face mask), on the face of a patient tointerface the ventilator or pressure support system with the airway ofthe patient so that a flow of breathing gas can be delivered from thepressure/flow generating device to the airway of the patient.

One class of respiratory face mask assemblies can be of two differenttypes: a single limb circuit type and a dual limb circuit type. For asingle limb circuit, the face mask assembly typically includes a valveand an exhaust port, and, for a dual limb circuit, the face maskassembly typically does not include a valve but provides a valvelessconduit instead. Other types of masks may also be useful for differentapplications. Thus, hospitals and other health care facilities typicallystock several different types of face mask assemblies that are used fordifferent applications. Cost and storage space considerations associatedwith stocking several different face mask assemblies can be significant.

A particular segment of the population which for which hospitalsgenerally do not stock dedicated masks are pediatric patients. Onereason masks for such patients are not stocked is the small demand. Abigger reason, is a lack of masks available for use on pediatricpatients, particularly for the smallest of such patients.

Accordingly, a need exists for a patient interface assemblies thatimprove upon existing assemblies, for example, to maximize patientcomfort while minimizing leak, during delivery of a positive airwaypressure or flow of gas to the airway of a pediatric patient.

SUMMARY OF THE INVENTION

As one aspect of the invention a mask assembly for use in a systemdelivering a flow of a treatment gas to the airway of a pediatricpatient is provided. The mask assembly comprises: a mask body having anopening adapted to receive a treatment gas supply and a flexibleperipheral seal structure having a first side coupled to the mask bodyand an opposite second side including an opening adapted to receive theface of the pediatric patient such that the second side sealinglyengages the perimeter of the pediatric patient's face. The opening isdefined by a height and a width, and the ratio of the height to width ofthe opening is in the range of about 0.83 to about 0.87. In oneembodiment, the opening may have a height of about 60.5 mm and a widthof about 73 mm.

The pediatric mask assembly may further comprise a headgear assemblyselectively coupled to the mask body. The headgear assembly may comprisea bonnet-style headgear assembly. The headgear assembly may comprise acolor indicative of the gender of the pediatric patient for which theassembly is intended. The headgear assembly may be one of: a shade ofthe color blue to indicate a male pediatric patient or a shade of thecolor pink to indicate a female patient.

As another aspect of the invention, a system for delivering treatmentgas to the airway of a pediatric patient is provided. The systemcomprises a pressure/flow generating system, a tubing element having afirst end coupled to the pressure/flow generating system and an oppositesecond end, a mask assembly as previously discussed, and a headgearassembly selectively coupled to the mask body.

As yet another aspect of the invention, a kit is provided. The kitcomprises a mask assembly, as previously described, and a plurality ofheadgear assemblies, each headgear assembly being selectively coupled tothe mask assembly. At least one headgear assembly comprises a coloradapted to indicate a male patient and at least another one headgearassembly comprises a color adapted to indicate a female patient.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a system including a mask assemblydisposed on a pediatric patient's face in accordance with an embodimentof the present invention;

FIG. 1B is a left side perspective view of the system and mask assemblyof FIG. 1A;

FIG. 2 is a perspective view of the mask assembly of FIGS. 1A and 1Bcoupled to an entrainment valve assembly in accordance with anembodiment of the present invention;

FIG. 3 is a perspective exploded view of a mask assembly in accordancewith an embodiment of the present invention;

FIG. 4 is a perspective view of an air entrainment valve with exhaustport assembly in accordance with an embodiment of the present invention;

FIG. 5 is another perspective view of the air entrainment valve withexhaust port assembly of FIG. 4;

FIG. 6 is a cross-sectional view of the mask assembly of FIG. 2;

FIG. 7 is a cross-sectional view of the entrainment valve assembly andbreathing circuit interface of the mask assembly of FIG. 2;

FIG. 8 is an elevational view of the patient side of the mask assemblyof FIGS. 2; and

FIG. 9 is a perspective view of the lower patient side of the maskassembly of FIG. 2.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

As used herein, the singular form of “a”, “an”, and “the” include pluralreferences unless the context clearly dictates otherwise. As usedherein, the statement that two or more parts or components are “coupled”shall mean that the parts are joined or operate together either directlyor indirectly, i.e., through one or more intermediate parts orcomponents, so long as a link occurs. As used herein, “directly coupled”means that two elements are directly in contact with each other. As usedherein, “fixedly coupled” or “fixed” means that two components arecoupled so as to move as one while maintaining a constant orientationrelative to each other. As used herein, the phrase that two or moreelements are “selectively coupled” shall mean the elements are coupledin a manner that may be readily positioned in either of a coupled oruncoupled position.

As used herein, the word “unitary” means a component is created as asingle piece or unit. That is, a component that includes pieces that arecreated separately and then coupled together as a unit is not a“unitary” component or body. As employed herein, the statement that twoor more parts or components “engage” one another shall mean that theparts exert a force against one another either directly or through oneor more intermediate parts or components. As employed herein, the term“number” shall mean one or an integer greater than one (i.e., aplurality).

Mask embodiments designed in accordance with the present invention arespecifically designed for the particular facial shape/structure of ayoung child from birth to 18 months, hence the phrase “pediatricpatient” shall mean a patient that is 18 months old or younger. Suchyoung children typically display a facial shape/structure having afacial height to width ratio in the range of about 0.83 to about 0.87.Such facial shape/structure is in contrast to a typical child/adultfacial shape/structure which has a height to width ratio of 1.0.Accordingly, conventional full-face masks suitable for children andadults will not work for the intended pediatric patients to whichembodiments of the present invention are directed.

Directional phrases used herein, such as, for example and withoutlimitation, top, bottom, left, right, upper, lower, front, back, andderivatives thereof, relate to the orientation of the elements shown inthe drawings and are not intended to be limiting upon the claims unlessexpressly recited therein.

FIGS. 1A, 1B and 2-9 show a mask assembly 10 and related components foruse in therapeutic gas delivery in accordance with an embodiment of thepresent invention. Referring to FIGS. 1A, 1B, 2 and 3, mask assembly 10may generally include a mask body 12 having an opening 13 for receptionof a breathing gas supply. Mask body 12 includes a seal structure 20 forsealingly engaging with the face of a pediatric patient 27 (FIG. 1A) insurrounding relation to at least the nose and mouth (and optionally theeyes) of pediatric patient 27. As shown in FIG. 6, mask assembly 10 hasa total depth D_(T) at outer edges in an area that would generallycoincide with a pediatric patient's temples and a central depth D_(C)that is less than total depth D_(T) due to the generally curved shape ofseal structure 20, as perhaps best shown in FIG. 9. In an exampleembodiment, mask assembly 10 has a total depth D_(T) of about 67 mm anda central depth D_(C) of about 48 mm.

Mask assembly 10, in one embodiment, also includes a breathing circuitinterface 16 for connecting mask body 12 with a pressurized breathinggas supply. As disclosed in more detail below, breathing circuitinterface 16 has a first portion 17 rotatably connected with mask body12 and a second portion 19 constructed and arranged to connect with aconduit 18 for delivering the breathing gas supply to pediatric patient27 through opening 13.

In an example embodiment, breathing circuit interface 16 and conduit 18connect mask body 12, via a circuit tubing 40, to a pressure/flowgenerating system 42 (shown schematically in FIGS. 1A and 1B), such as aventilator, CPAP device, or variable pressure device, e.g., a BiPAP®positive pressure therapy device manufactured and distributed by PhilipsRespironics, Inc. of Pittsburgh, Pa., or an auto-titration pressuresupport system. Such combination of elements is typically referred to asa “system” for delivering treatment gas to a patient.

A BiPAP device is a bi-level device in which the pressure provided tothe patient varies with the patient's respiratory cycle, so that ahigher pressure is delivered during inspiration than during expiration.An auto-titration pressure support system is a system in which thepressure varies with the condition of the patient, such as whether thepatient is snoring or experiencing an apnea or hypopnea. For presentpurposes, pressure/flow generating system 42 is also referred to as agas flow generating device, because gas flow results when a pressuregradient is generated. The present invention contemplates thatpressure/flow generating system 42 is any conventional system fordelivering a flow of gas to an airway of a patient or for elevating apressure of gas at an airway of the patient, including the pressuresupport systems summarized above and non-invasive ventilation systems.

As will be appreciated from further discussions herein, second portion19 of breathing circuit interface 16 is releasably connected withconduit 18 to enable different types of conduits 18 to be connected tomask body 12. Accordingly, it is to be appreciated that other conduitsbeyond those described in detail herein may be employed with mask body12 without varying from the scope of the present invention. In addition,a rotatable or swivel connection between breathing circuit interface 16at first portion 17 thereof with mask body 12 allows elbow shapedconduit 18 to rotate after connection to enable conduit 18 to extend inany direction within 360° of rotation for connecting with tubing 40. Itshould be appreciated that for some purposes breathing circuit interface16 may also be considered to be part of mask body 12.

As shown in FIG. 3, breathing circuit interface 16 has an annularconfiguration with a generally cylindrical inner surface 23 disposedabout a central opening, shown generally at 29, therethrough. As will beappreciated from more detailed discussions later, cylindrical innersurface 23 of breathing circuit interface 16 is shaped and configured toprovide a releasable friction fit with a generally cylindrical matingsurface 25 of an appropriate conduit 18 that connects with tubing 40 forreceiving a breathable gas.

In the exemplary embodiment, such as that shown in FIG. 3, breathingcircuit interface 16 includes a plurality of radially outwardlyextending ribs 31 spaced at regular circumferential intervals about theouter surface (not numbered) thereof. Each of ribs 31 have an increasingthickness or radial dimension as they extend from second portion 19 tofirst portion 17 of breathing circuit interface 16. Ribs 31 areintegrally formed as part of the outer surface of breathing circuitinterface 16. The plurality of ribs 31 located on the outer surface ofsecond portion 19 of breathing circuit interface 16 provides healthcarepersonnel a grip to hold breathing circuit interface 16 when connectingand disconnecting conduit 18 to breathing circuit interface 16. Ribs 31also facilitate manual rotation of breathing circuit interface 16. Thepresent invention contemplates that any technique for coupling thebreathing circuit to the mask body can be used in mask assembly 10.

In one example embodiment, mask body 12 includes a rigid portion 21,formed from a clear plastic material, and the aforementioned flexibleperipheral seal structure 20. Flexible peripheral seal structure 20 isattached around rigid portion 21 of mask body 12.

In one example embodiment, such as shown in FIGS. 1A and 1B, mask body12 is adapted to be connected with a headgear assembly 11 that can beused to mount mask body 12 on the head of pediatric patient 27. In anexample embodiment, a pair of headgear attachment clips 14 are providedfor interface and connection with lower headgear mounting strap portions44 of headgear assembly 11. A pair of headgear attachment members 22(FIG. 3) is provided for connectably receiving headgear attachment clips14, and a pair of spaced upper headgear strap retaining tabs 24, eachhaving an elongated opening 50 therethrough, is provided for receivingupper headgear mounting strap portions 46 of headgear assembly 11. Thepair of headgear retaining tabs 24 is disposed on the opposite uppersides of rigid portion 21 of mask body 12. The pair of headgearattachment members 22 is disposed on opposite, lower sides of rigidportion 21 of mask body 12. Each headgear retaining tab 24 is integrallyformed with rigid portion 21 and extends outwardly from flexibleperipheral seal structure 20, as perhaps best seen in FIGS. 2 and 3.

In an example embodiment, mask assembly 10 is characterized by mask body12 having a weight of 20.27 grams (g), seal structure 20 having a weightof 33.72 g, mask assembly 10 along with breathing circuit interface 16and elbow having a weight (no headgear) of 98.24 g, and mask assembly 10with headgear having a weight of 124.10 g.

FIG. 4 shows a conduit 18 in accordance with one embodiment. In thisembodiment, conduit 18 is an entrainment valve assembly 200. Entrainmentvalve assembly 200 comprises a generally elbow shaped tubular member 201formed from a rigid plastic material, such as polycarbonate or otherplastic material as would be appreciated by one skilled in the art. Inone example embodiment, tubular member 201 is formed from a clear,colorless, plastic material. In another example embodiment, tubularmember 201 is formed from an orange/amber colored material, howevermembers of other colors and/or opacity may be employed without varyingfrom the scope of the present invention. Tubular member 201 includes aprimary inlet 202, a secondary inlet 204 and an outlet 206.

Tubular member 201 includes a first connector portion 230 and a secondconnector portion 232. First connector portion 230 and second connectorportion 232 are generally cylindrical in shape and are generallydisposed perpendicular to each other. First connector portion 230 andsecond connector portion 232 are joined by a bent tubular region 233.First connector portion 230 has aforementioned generally cylindricalouter surface 25 for connection with breathing circuit interface 16,while second connector portion 232 also has a cylindrical outer surface205 for frictionally mating with inner surfaces of tubing 40 forreceiving pressurized gas from a pressure/flow generating system 42.

Secondary inlet 204 of entrainment valve assembly 200 comprises anopening 254 located towards bent tubular region 233. Opening 254 isdivided into two equal, generally semi-cylindrical segments by a planarwall 256. Planar wall 256 of entrainment valve assembly 200 extendsthrough cylindrical opening 254. Opening 254 allows pediatric patient 27to breath in from and out to atmosphere in the absence of a pressurizedgas flow being provided into inlet 202. Entrainment valve assembly 200,at cylindrical surface 25, further includes a plurality of exhalationgrooves 258. Grooves 258 are located at an interface where entrainmentvalve assembly 200 connects with breathing circuit interface 16. Theplurality of exhalation grooves 258 are circumferentially spaced onsurface 25 and placed symmetrically on either side of first connectorportion 230. Other example embodiments are contemplated in whichexhalation grooves 258 are located anywhere on the outer surface offirst connector portion 230, where it interfaces with breathing circuitinterface 16.

Exhalation grooves 258 are sufficiently long so that, when entrainmentvalve assembly 200 is pushed as far as it can go into breathing circuitinterface 16 (such as shown in FIGS. 1A, 1B and 2), grooves 258 stillextend outwardly from breathing circuit interface 16 and provide a pathfor allowing gases exhaled from the pediatric patient to exit throughgrooves 258. In addition, for any extent of friction fitting engagementbetween surfaces 23 and 25, the cross-sectional area of the gap or spaceprovided by grooves 258 will be constant, so that the expired gas flowpath to the exterior of mask body 12 provides constant resistance,irrespective of whether entrainment valve assembly 200 is fully insertedor somewhat less than fully inserted into breathing circuit interface16.

Referring to FIGS. 3 and 5, entrainment valve assembly 200 includes apressure port 260 which extends from bent tubular region 233 ofentrainment valve assembly 200 and is generally parallel to secondconnector portion 232 of entrainment valve assembly 200. A removable cap262 is used to close pressure port 260. Cap 262 includes a gripping tab264 to aid in removal of cap 262 from pressure port 260. A sampling tube(not shown) may be disposed in fluid communication with the gas withintubular body 201 via pressure port 260. A transducer (not shown) can besecured to the sampling tube in conjunction with a processor whichcommunicates with the transducer. The processor calculates at least onerespiratory parameter using the signal from the transducer. Sucharrangement is generally used to measure pressure by the ventilator ascontrol feedback to the ventilator.

As shown in FIGS. 6 and 7, breathing circuit interface 16 includes theaforementioned first portion 17 and second portion 19. First portion 17is generally circular in shape and includes an annular flat wall 408that engages a radially inwardly extending flange portion 70 in slidablesurface relationship. Flange portion 70 surrounds opening 13 in rigidportion 21 of mask body 12 (see FIG. 3). First portion 17 of breathingcircuit interface 16 further includes a generally cylindrical protrudingportion 409 that extends outwardly from a radially innermost portion ofannular surface 408. Cylindrical protruding portion 409 extends intoopening 13 in rigid portion 21 of mask body 12. Cylindrical protrudingportion 409 includes a groove 410 located in the outer cylindricalsurface thereof (see FIG. 7). Groove 410 accommodates a connectingwasher or a bearing 412. Washer 412 in one embodiment is a split ringwasher structure that has an outer periphery thereof that bears againstthe inner surface of flange 70, and its inner periphery received ingroove 410 so as to rotatably connect breathing circuit interface 16with mask body 12. Thus, breathing circuit interface 16 is rotatablyconnected with rigid portion 21 of mask body 12. Slight friction at therotatable interface may, in one embodiment, provide at least resistanceto rotation, so that the rotational position of breathing circuitinterface 16 can be manually set as desired, and it will retain thatposition so that the leg or second connector portion 232 of conduit 18that connects with tubing 40 can be positioned in a desired directionthat is generally retained unless intentionally altered. In anotherembodiment, the friction at the point of rotation can be minimal, toallow free rotation of breathing circuit interface 16.

In another embodiment, the connection between breathing circuitinterface 16 and rigid portion 21 of the mask body 12 may be achieved byusing a ball bearing arrangement or any other type bearing arrangementthat allows a rotating motion of breathing circuit interface 16 withrespect to mask body 12.

As discussed above, inner surface 23 of breathing circuit interface 16is shaped and configured to engage detachably with outer surface 25 ofentrainment valve assembly 200 by a friction-fit. In addition toallowing friction fit with entrainment valve assembly 200, inner surface23 of breathing circuit interface 16 allows entrainment valve assembly200 to be removed and interchangeably friction fitted with different,other types of conduits 18 through a similar friction fit, as will bedescribed in more detail later. In an example embodiment, the diameterof first connector portion 230 is larger than the diameter of secondconnector portion 232 of entrainment valve assembly 200 to prevent thewrong end of valve assembly 200 from being connected with interface 16.

Continuing to refer to the cross-sectional views of FIGS. 6 and 7,entrainment valve assembly 200 includes a valve member 208. Valve member208 is connected to tubular member 201 at connection region 248 thereofby means of a recess 250, a barb 526 and a stop member 528 provided inthe valve member 208. A rib 252 (FIG. 7), located on the lower portionof bent tubular region 233 of entrainment valve assembly 200, has anouter surface thereof that is received in recess 250 so as to clampconnecting region 248 against an annular region 253.

Valve member 208 includes a sealing portion 520, having a relativelythin, flat, oval configuration. Sealing portion 520 is made of aflexible material and thus is capable of bending upwardly (as shown inthe dashed lines in FIG. 7) in response to pressurized gas being forcedinto primary inlet 202. The upward bending continues until an uppersurface 522 of sealing portion 520 engages an annular lip 235 at the endof a cylindrical wall 254 protruding into tubular body 201 and definingsecondary inlet 204. The direction of travel of sealing portion 520 fromits rest position to the upper bent portion is shown by arrow A in FIG.7. In this upper bent portion, the sealing engagement of upper surface522 of valve member 208 with annular lip 235 causes secondary inlet 204to be sealed so that pressurized gas provided into primary inlet 202does not escape through secondary inlet 204.

It should be noted that where gas is not being provided to the pediatricpatient through primary inlet 202 (e.g., pressure/flow generating system42 connected with primary inlet 202 is not operating), secondary inlet204 may serve as both an inlet passage of atmospheric air provided tothe pediatric patient during inhalation and an outlet passage forexhalation. In this instance, sealing portion 520 may remain at its atrest position, wherein it forms a seal with an upper surface 259 ofannular flange 253, as shown in FIG. 7.

Valve member 208 can be made from rubber, latex, silicone, or any otherelastomeric material as would be appreciated by one skilled in the art.

As can be appreciated most readily from FIGS. 2 and 4, exhalationgrooves 258 form a passage between exterior surface 25 of tubularportion 201 and interior cylindrical surface 23 of breathing circuitinterface 16. In one embodiment, exhalation grooves 258 are provided onopposite lateral sides of exterior surface 25 of tubular portion 201. Inanother embodiment, exhalation grooves may be provided on inner surface23 of breathing circuit interface 16 rather than on body 201. Inaddition, as shown as dashed lines in FIG. 7, in another embodiment theymay alternatively, or also, be located at the top portion of exteriorsurface 25 of body 201. When the pediatric patient inhales, a very smallfraction of gas may be drawn from atmosphere through exhalation grooves258. However, by and large, the pressurized gas forced into primaryinlet 202 will create higher pressure within body 201 than theatmospheric pressure, so that air is mostly forced outwardly throughexhalation passages 258 (rather than inwardly), even during inhalation.Moreover, as the pediatric patient exhales, the exhaled gas impacts thecentrally incoming airflow through body 201 and is thus forced tomushroom radially outwardly resulting in a circular flow pattern thateffectively flushes the exhaled gas, and is thus generally directedtoward and through peripheral exhalation grooves 258 to atmosphere.

The removable and replaceable conduits 18 enable mask assembly 10 to befunctional for different uses, simply by employing the conduit 18 ofchoice. Although shown with a conduit 18 that is adapted to accommodateentrainment valve assembly 200, it is to be appreciated that the presentinvention contemplates that other conduits 18 may be employed with maskassembly 10 without varying from the scope of the present invention.Some non-limiting examples of other types of conduits 18 that can beused interchangeably with mask assembly 10 described above include:conduit with a bronchoscope port to permit the care giver to perform abronchoscopy procedure with mask on; conduit with aerosol generatoradapter to deliver medication during NIV; conduit with MDI port todeliver medication using a “Metered Dose Inhaler”; conduit with port toaccommodate a CPAP relief valve; conduit with CO₂ sensor capabilities tomonitor pediatric patient; conduit with Volumetric CO₂ sensorcapabilities to monitor pediatric patient VCO₂; conduit that entrainsHeliox or other specialty gases; conduit that adds moisture to inhaledgas; conduit that includes an HME (Heat moisture exchanger); conduitthat incorporates “nano” sensors for a variety of clinical monitoringcapabilities; conduit with Filtered Exhalation, which is useful inpandemic situations like SARS; conduit that enhances the patient'sability to “Speak with Mask On”; conduit that accommodates a NG feedingtube; conduit that reduces/control CO₂ re-breathing; conduit that aidsin secretion clearance; conduit with Standard Elbow; conduit that can beused on a wide range of mask types, such as full (nasal/oral), nasalonly, cannula, pillows, or total or Helmet type of masks.

It should be appreciated, that the above listed conduit configurationsprovide non-limiting examples of different types, configurations and/orconstructions of conduits that can be provided. It should be appreciatedthat, while these conduits may all be provided with an elbow shapedtubular body, other tubular shapes (such as a straight tubularconfiguration) may alternatively be provided.

Other embodiments in accordance with the present invention arecontemplated in which the connection between conduit 18 and breathingcircuit interface 16 is not a friction fit, but may be achieved byvirtue of other types of connections such as, for example, withoutlimitation, a quarter-turn type connection, a snap fit, or any otherlocking mechanism that provides a detachable connection between conduit18 and breathing circuit interface 16.

In yet another embodiment, first connector portion 230 of conduit 18 mayitself be provided with a swivel coupling, similar to breathing circuitinterface 16, rather than such structure being provided as part of themask. In such case, the swivel coupling of the elbow can be connecteddirectly to a non-swiveled portion (e.g., an outwardly projectingcylindrical configuration) surrounding opening 13 in rigid portion 21 ofmask body 12.

In yet another embodiment, no swivel coupling is provided. Rather, adirect connection between the tubular body (e.g., 201) is provided witha correspondingly shaped portion of rigid portion 21 of the mask. Inthis embodiment, some rotation of conduits 18 may nevertheless beaccommodated via direct sliding friction at the friction fit connectionbetween rigid portion 21 and the tubular body. However, it is furthercontemplated that other, non-rotational connections may also be providedand will still enable the modularity of design contemplated herein.

In one aspect of the invention, a mask assembly kit is provided. The kitassembly includes mask body 12, with or without rotatable interface 16,and at least two conduits 18 of different types to enable mask body 12to provide different functionality simply by changing conduit types. Forexample, a standard (valveless) elbow can be provided as one conduit,and the entrainment valve assembly 200 can be provided as anotherconduit. More than two conduits may be provided, and more than one maskmay be provided, although each of the masks will have a commonconfiguration, while the conduits will have at least two differentconfigurations that fit the mask body. Additionally, an embodiment ofthe kit includes a plurality of headgear assemblies 11, with at leastone headgear assembly being a color indicative of a male pediatricpatient and another headgear assembly being a color indicative of afemale patient, as discussed in greater detail below.

Referring to FIGS. 6, 8 and 9, details of flexible peripheral sealstructure 20 will now be discussed. As best seen in FIG. 6, flexibleperipheral seal structure 20 may have a generally rectangular channelshaped cross-sectional configuration with three sides 504, 506 and 508.Flexible peripheral seal structure 20 may be attached to mask body 12 atside 504. An edge 500 of rigid portion 21 of mask body 12 engages withan opening 502 located in side 504 of flexible peripheral seal structure20, such that a layered connection is formed. The parts are then adheredin place, through an adhesive connection, an ultrasonic weld connection,a riveted, a pinned connection, or any other type of suitable connectionas would be appreciated by one skilled in the art. Other embodiments arecontemplated in which there is no overlap, such as by attaching rigidportion 21 and flexible peripheral seal structure 20 with their edgesend to end (e.g., by an adhesive connection). Side 506 is locatedbetween side 504 and side 508, providing a gap between sides 504 and508. This gap may provide flexibility to flexible peripheral sealstructure 20, as it conforms to the face of the pediatric patient 27.The corners of flexible peripheral seal structure 20 may be generallyrounded. The length of sides 508 and 506 may vary along the periphery ofseal structure 20 so as to provide a conforming sealing engagement ofmask body 12 with the face of pediatric patient 27.

More particularly, as shown in the elevation view of FIG. 8, side 508 ofperipheral seal structure 20 has a general overall height H_(O) and anoverall width W_(O) and includes an opening, generally indicated at 510,that is particularly adapted to receive the pediatric patient's facetherein, and thus provide for side 508 to sealingly engage the face ofpediatric patient 27 about the edges of the patient's face. In order toaccomplish such fitment, opening 510 is dimensioned having a heightH_(I) and a width W_(I) proportioned specifically to a pediatricpatients face. Side 508 is generally designed such that, at minimum, aseal is created about the pediatric patient's face at or about themidpoints between opening 510 and the outer edge of side 508. Thegeneral height and width of such minimum sealing region is shown in FIG.8 by the dimensions H_(M) and W_(M), respectively.

In an example embodiment, the ratio of height H_(I) to width W_(I) isabout 0.83, in contrast to a typical ratio of about 1.0 which would benecessary to accommodate an adult patient's face. In other embodiments,the ratio of height H_(I) to width W_(I) is in the range of about 0.83to about 0.87. In an example embodiment, opening 510 has a height H_(I)of about 60.5 mm and a width W_(I) of about 73.0 mm, and thus a heightto width ratio of about 0.83. In the same example embodiment, side 508also has an overall height H_(O) of about 87.9 mm, an overall width ofabout 100.5 mm, and intermediate dimensions H_(M), W_(M) of 74.8 mm and86.9 mm, respectively.

In an example embodiment, the size of the face mask is embossed on thelower end portion of flexible peripheral seal structure 20, as shown by600 in FIG. 9.

Flexible peripheral seal structure 20 may be made of a relatively softand/or flexible material so that flexible peripheral seal structure 20conforms to the shape of a pediatric patient's face when held againstit. In an example embodiment, a material having a 20 durometer (ascompared to a 40 durometer material commonly employed in adultapplications) was employed. Flexible peripheral seal structure 20 may bemade of, for example, silicone, an elastomeric material or any othersuitable shape conforming material as will be appreciated by one skilledin the art. Different regions of the flexible peripheral seal structure20 around the perimeter of mask body 12 may have differentcross-sectional configurations. Various other flexible peripheral sealstructure 20 configurations will become apparent to those skilled in theart. Rigid portion 21 of mask body 12, in one embodiment, is made of arelatively more rigid material than flexible peripheral seal structure20. For example, mask body 12 may be made from polycarbonate, or othersuitable material.

Mask body 12 may be formed by a two-step insert molding process. Forexample, rigid portion 21 may be molded first and then inserted into asecond mold for flexible peripheral flexible peripheral seal structure20, which is injection molded to form around and/or into rigid portion21.

In an example embodiment, mask assembly 10 includes a mask body 12having a part volume of 17.02 cm³ and a seal structure 20 having a partvolume of 34.11 cm³.

In one embodiment, headgear assembly 11 that is used to mount mask body12 to the head of pediatric patient 27 takes the form of a bonnet havingstraps. However, any structure that secures mask body 12 to the head ofa pediatric patient can be used. In one embodiment, headgear assembly 11is provided in three different colors, a shade of pink for girls, ashade of blue for boys, and a gender neutral color (e.g., yellow). Inthe illustrated embodiment as shown in FIGS. 1A and 1B, an end portion(not numbered) of each of two headgear straps 46 (only one shown in FIG.1B) is threaded through elongated opening 50 of headgear retaining tab24, and the end portion (not numbered) of lower headgear straps 40 arethreaded through the elongated opening 130 of the headgear attachmentclip 14. In one embodiment, the end portions comprise hook material andis bent back into engagement with the adjoining surface formed of loopmaterial on the straps so as to form a hook and loop (or VELCRO™) typeconnection. It is to be appreciated, however, that there are numerousother ways for securing the end portion of the headgear strap to itselfor to the headgear attachment clip 14 and/or to the headgear attachmenttab 24, such as a snap connection, buckle, or locking clamp, asnon-limiting examples. Headgear 11 is adjustable, as straps 44,46 can bepulled further through the opening 50 of the headgear retaining tab 24or the elongated opening of headgear attachment clip 14 to accommodatesmaller diameter head sizes.

In addition, in another embodiment, a more permanent attachment of theend portion of headgear straps 44,46 to headgear strap retaining tabs 24or headgear attachment clips 14 may be provided. For example, onceheadgear assembly 11 has been fitted to the pediatric patient 27 byadjusting straps 44,46 to the desired lengths, the free ends of straps44,46 can be permanently fixed back onto straps 44,46, such as bygluing, sewing, or riveting the overlapping straps together. Straps44,46 of headgear assembly 11 may be elastic or inelastic, and mayextend around the back of the head of the pediatric patient 27 to securemask body 12 on the pediatric patient 27, with the flexible peripheralseal structure 20 in sealing engagement with the pediatric patient'sface.

In the claims, any reference signs placed between parentheses shall notbe construed as limiting the claim. The word “comprising” or “including”does not exclude the presence of elements or steps other than thoselisted in a claim. In a device claim enumerating several means, severalof these means may be embodied by one and the same item of hardware. Theword “a” or “an” preceding an element does not exclude the presence of aplurality of such elements. In any device claim enumerating severalmeans, several of these means may be embodied by one and the same itemof hardware. The mere fact that certain elements are recited in mutuallydifferent dependent claims does not indicate that these elements cannotbe used in combination.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

1. A mask assembly for use in a system delivering a flow of a treatmentgas to the airway of a pediatric patient, the mask assembly comprising:a mask body having an opening adapted to receive a treatment gas supply;and a flexible peripheral seal structure having a first side coupled tothe mask body and an opposite second side including an opening adaptedto receive the face of the pediatric patient such that the second sidesealingly engages the perimeter of the pediatric patient's face, whereinthe opening is defined by a height (H) and a width (W), and wherein theratio of the height to width of the opening is in the range of about0.83 to about 0.87.
 2. The pediatric mask assembly of claim 1, whereinthe ratio of the height to width of the opening is about 0.83.
 3. Thepediatric mask assembly of claim 1, wherein the opening has a height ofabout 60.5 mm and a width of about 73.0 mm.
 4. The pediatric maskassembly of claim 1, further comprising a headgear assembly selectivelycoupled to the mask body.
 5. The pediatric mask assembly of claim 4,wherein the headgear assembly comprises a bonnet-style headgearassembly.
 6. The pediatric mask assembly of claim 5, wherein theheadgear assembly comprises a color indicative of the gender of thepediatric patient for which the assembly is intended.
 7. The pediatricmask assembly of claim 6, wherein the headgear assembly is one of: acolor of blue to indicate a male pediatric patient or a color of pink toindicate a female patient.
 8. A system for delivering treatment gas tothe airway of a pediatric patient, the system comprising: apressure/flow generating system; a tubing element having a first endcoupled to the pressure/flow generating system and an opposite secondend; a mask assembly comprising: a mask body having an opening coupledto the second end of the tubing element and adapted to receive atreatment gas supply from the pressure/flow generating system via thetubing element; and a flexible peripheral seal structure having a firstside coupled to the mask body and an opposite second side including anopening adapted to receive the face of the pediatric patient such thatthe second side sealingly engages the perimeter of the pediatricpatient's face; and a headgear assembly selectively coupled to the maskbody, wherein the opening in the second side of the flexible peripheralseal structure is defined by a height (H_(O)) and a width (W_(I)), andwherein the ratio of the height to width of the opening is in the rangeof about 0.83 to about 0.87.
 9. The system of claim 8, wherein theopening the second side of the flexible peripheral seal structure has aheight of about 60.5 mm and a width of about 73 mm.
 10. The system ofclaim 8, wherein the headgear assembly comprises a bonnet-style headgearassembly.
 11. The system of claim 10, wherein the headgear assemblycomprises a color indicative of the gender of the pediatric patient forwhich the assembly is intended.
 12. The system of claim 11, wherein theheadgear assembly is one of: a color of blue to indicate a malepediatric patient or a color of pink to indicate a female patient.
 13. Akit comprising: a mask assembly for use in a system delivering a flow ofa treatment gas to the airway of a pediatric patient, the mask assemblycomprising: a mask body having an opening adapted to receive a treatmentgas supply; and a flexible peripheral seal structure having a first sidecoupled to the mask body and an opposite second side including anopening adapted to receive the face of the pediatric patient such thatthe second side sealingly engages the perimeter of the pediatricpatient's face, wherein the opening is defined by a height (H_(I)) and awidth (W_(I)), and wherein the ratio of the height to width of theopening is in the range of about 0.83 to about 0.87; and a plurality ofheadgear assemblies, each headgear assembly being selectably coupleableto the mask assembly, wherein at least one headgear assembly comprises acolor adapted to indicate a male patient and wherein at least anotherone headgear assembly comprises a color adapted to indicate a femalepatient.
 14. The kit of claim 13, wherein each headgear assemblycomprises a bonnet-style headgear assembly.
 15. The kit of claim 14,wherein the color adapted to indicate a male patient comprises a shadeof blue and wherein the color adapted to indicate a female patientcomprises a shade of pink.